Senior Director, Clinical Data Management, Therapeutic Area Lead, Melanoma, Hybrid

MSD•North Wales, PA

1d•$173,200 - $272,600•Hybrid

About The Position

The Senior Director, Clinical Data Management TA Lead, Melanoma provides strategic and operational oversight of data management delivery across the assigned therapeutic area(s). The role leads portfolio planning, resource and performance management, and cross-functional alignment to ensure execution against GDMS and enterprise priorities. The Senior Director partners with Therapeutic Area (TA), Geography (Geo), and Capability Leads to optimize efficiency, standardization, and digital enablement across programs, while driving quality, compliance, and continuous improvement within the TA organization.

Requirements

Deep experience leading end-to-end data management for clinical trials, including database design/build/UAT (User Acceptance Training), edit checks/validation, review/reconciliation, database lock, and the design, validation, and maintenance of DM (Data Management) deliverables using relevant Clinical Data Manager platforms and enabling technologies.
Deep understanding of data structures and integrations across EDC (Electronic Data Capture) and connected systems (e.g., labs, IRT [Interactive Response Technology], eCOA [electronic Clinical Outcome Assessment], imaging), with a demonstrated ability to triage and resolve complex study-level issues to maintain data integrity across internal systems and service providers.
Advanced knowledge across two or more Therapeutic Areas, applying TA-specific scientific and operational expertise to shape indication- and TA-level data management strategy, planning, resource allocation, and execution.
Comprehensive knowledge of the clinical development lifecycle, data flow, and cross-functional dependencies (Clinical Operations, Biostatistics, Safety, Data Standards, Regulatory), supported by a deep understanding of clinical practice and medical terminology.
Advanced proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards (CDASH [Clinical Data Acquisition Standards Harmonization], SDTM [Study Data Tabulation Model], Define-XML), metadata management, and controlled terminologies (e.g., LOINC [Logical Observation Identifiers Names and Codes]) to ensure consistency and submission readiness.
Working knowledge of SOPs (Standard Operating Procedures), ICH-GCP (International Council for Harmonization – Good Clinical Practice), 21 CFR Part 11/Annex 11, and privacy expectations, applying risk-based, data-driven approaches (RBQM [Risk Based Quality Management]) to prevent or mitigate issues.
Strategic leadership with the ability to align different teams and stakeholders around shared TA objectives.
Strong people leadership, mentoring, and development capabilities across multiple levels and geographies.
Advanced stakeholder management and negotiation skills across functions and seniority levels.
Ability to lead change, embed innovation, and drive continuous improvement initiatives.
Resilient and adaptable, with a balance of strategic vision and operational execution.
Ability to integrate business, operational, and people dimensions to effective decision-making.
Networking & Partnerships | Develops and maintains strategic relationships with internal and external stakeholders to bring forward the information, perspectives, expertise, and influence needed to address issues and advance organizational goals.
Coaching & Development | Provides feedback, guidance, and development support to help others excel in current and future roles, while actively building the skills and capabilities needed for individual and organizational success of Clinical Data Manager.
Strategic Planning | Identifies and evaluates the key issues, trends, and cross-functional interdependencies most relevant to long-range goals. Uses facts, assumptions, resource constraints, and organizational priorities to define an effective path forward that supports the long-term success of the Clinical Data Manager organization.
Bachelors of Arts or Science in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with 13 years of experience in clinical data management, clinical trial operations or related field, including 5 years of people management experience. Demonstrate deep SME (Subject Matter Expert) in relevant discipline.
OR Bachelors of Arts or Science (or equivalent educational experience) in any field not listed above with 18 years of experience in clinical data management, clinical trial operations or related field, including 5 years of people management experience. Demonstrate deep SME (Subject Matter Expert) in relevant discipline.
OR Advanced Degree (preferred) (Masters or Doctorate) in Nursing, Pharmacy, Life sciences, Allied Health, Data / Information technology or Medical Technology with 10 years of experience in clinical data management, clinical trial operations or related field, including 5 years of people management experience. Demonstrate deep SME in relevant discipline.
OR Advanced Degree (preferred) (Masters or Doctorate) in any field not listed above with 15 years of experience in clinical data management, clinical trial operations or related field, including 5 years of people management experience. Demonstrate deep SME in relevant discipline.
AND Demonstrated experience in leading geographically different cross functional teams in delivery of clinical data management or clinical trial operations strategy, execution and submissions (Inspections & Health Authority Interactions & Responses).
Change Management
Clinical Data Standards
Clinical Trials Operations
Cross-Functional Teamwork
Data Governance
Decision Making
Ethical Standards
Good Clinical Practice (GCP)
Oncology
People Leadership
Stakeholder Relationship Management
Strategic Planning

Nice To Haves

Adaptability
Operational Execution
Strategic Thinking

Responsibilities

Accountable for TA (Therapeutic Area) portfolio strategy and prioritization, developing the TA roadmap and study sequencing, and balancing resources, timelines, and risks to meet enterprise commitments.
Partner with Clinical Data Manager Geographic Leadership to ensure seamless global delivery, effective knowledge sharing, in depth understanding of protocols, risk-based data management and quality-by-design execution proportionate to study design and therapeutic area risk management across all in-scope data modalities.
Partner with Clinical, BARDS (Biostatistics and Research Data Science), GDIA (Global Data Integration & Automation), GCDS (Global Clinical Data Standards), and platform/analytics teams to embed standards, automation, and data-integration practices into TA operating models; define requirements, drive adoption of fit-for-purpose tools, establish TA dashboards and KPIs, and scale successful automation pilots.
Forecast capability and capacity needs across regions and programs in partnership with Portfolio and Geographic Leads, optimizing onshore, offshore, and contingent delivery models.
Lead TA-wide quality governance, inspection readiness, and risk management; harmonize Corrective And Prevention Action (CAPA) tracking across the portfolio; and present TA performance in reviews with recommended corrective actions and structural improvements.
Serve as escalation point for complex study and program issues; capture and scale lessons learned and best practices; and partner with GDMS (Global Data Management & Standards), GCTO (Global Clinical Trial Operations), and GCD (Global Clinical Development) leadership on enterprise-aligned transformation initiatives (including but not limited to process, standards, and platform / tools), ensuring consistent cross-regional adoption and alignment with digital, data, and regulatory guardrails.
Set clear objectives aligned to organizational goals; assign work and set priorities.
Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.
Lead recruiting and hiring; manage sensitive employee-relations matters in partnership with HR.
Balance workloads to support value-added work and work–life sustainability; anticipate obstacles and adjust plans.
Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
Manage an operating budget and optimize spend against priorities.
Align teams around a clear direction; facilitate team/functional meetings.
Provide concise, decision-ready updates and status reporting to leadership and partners.
Sit on the CDM (Clinical Data Management) Leadership team as the representative for their assigned capability
Contributes to/ leads execution of the strategic objectives and roadmap for capability development initiatives aligned to business needs and industry best practices.
Supports governance aligned to GDMS/GCTO policies and enterprise digital / data initiatives.
Own development of critical capabilities (tools, processes, skills) aligned to business needs and industry best practices.
Establish capability governance aligned with GDMS/GCTO policies and enterprise digital/data initiatives.
Drive consistent global rollout via playbooks, guidance, and implementation support; align cross-regional ways of working with partners.